A statistical approach for the development of an oral controlled-release matrix tablet.
Tablet matrix compositions for optimized prolonged release were selected by surface response methodology. The extreme vertices experimental design was used to develop a surface response model which mathematically defined the release of active component from the tablet matrix as controlled by the percentage of the excipient components. The model, a statistical quadratic equation with a standard error of 3.3, was validated for accurate prediction of drug release profiles and used to identify optimum formulations. This study demonstrated a new application of the extreme vertices experimental design, an efficient method for evaluating a complex mixture system for controlled release, where specific constraints are placed on one or more of the components.
Johnson
A D
AD
Pharmaceutical R&D, Pfizer Central Research, Groton, Connecticut 06340.
Anderson
V L
VL
Peck
G E
GE
D000284:Administration, Oral; D000465:Algorithms; D003692:Delayed-Action Preparations; D006801:Humans; D015233:Models, Statistical; D012984:Software; D012995:Solubility; D013607:Tablets
D003692:Delayed-Action Preparations; D013607:Tablets